MAUDE Adverse Event Report: ARTHROCARE CORP. WEREWOLF RF 20000 CONTROLLER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 72290105

Device Problems Device Emits Odor (1425); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.There was a relationship between the returned device and the reported incident.Visual inspection of the returned controller found that the warranty seal was broken.The returned device was tested using a known good compatible wand which was found that when power was supplied the unit gave off a burnt smell and would not power up.The unit was opened and it was founds that the 48 volt diode for the power supply has one burnt lead and it was also noted that the sd card was damaged and unable to retrieve data as the card was melted.It was also noted that some type of fluid got inside the unit which cause the diode to short out.The complaint was verified and the root cause was determined to be due to electrical component failure.Factors which can lead to electrical short in the unit include: normal wear and tear, causing damage as a result of consistent use over time such as a fluid may have come into contact with the device causing the unit to short out.There were no indications to suggest the device did not meet product specifications upon release into distribution.

Event Description

It was reported that the unit isn't working properly and emits a burning smell.Additional information received via product evaluation 4/5/2018 indicates the device may have overheated.No patient involved.No user injury reported.

• Brand Name: WEREWOLF RF 20000 CONTROLLER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon; austin, TX 78735
• MDR Report Key: 7401957
• MDR Text Key: 105168504
• Report Number: 3006524618-2018-00173
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885556624890
• UDI-Public: 00885556624890
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72290105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1